(A) An
application for a specific license to manufacture and distribute sources and
devices containing radioactive material to persons licensed pursuant to Chapter
3701:1-58 of the Administrative Code or equivalent regulations of the United
States nuclear regulatory commission or agreement state for use as a
calibration, transmission, or reference source or for the uses listed in rules
3701:1-58-43,
3701:1-58-53,
3701:1-58-55, and
3701:1-58-72 of the
Administrative Code or equivalent regulations of the United States nuclear
regulatory commission or agreement state will be approved if:

(1) The applicant satisfies the general
requirements in rule
3701:1-40-15 of the
Administrative Code;

(2) The
applicant submits sufficient information regarding each type of source or
device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its
chemical and physical form, and amount;

(g) Legend and
methods for labeling sources and devices as to their radioactive
content;

(h) Instructions for
handling and storing the source or device from the radiation safety standpoint;
these instructions are to be included on a durable label attached to the source
or device or attached to a permanent storage container for the source or
device: provided, that instructions which are too lengthy for such label may be
summarized on the label and printed in detail on a brochure which is referenced
on the label;

(3) The
label affixed to the source or device, or to the permanent storage container
for the source or device, contains information on the radionuclide, quantity
and date of assay, and a statement that the director has approved distribution
of the (name of source or device) to persons licensed to use radioactive
material identified in rules
3701:1-58-26,
3701:1-58-43,
3701:1-58-53, and
3701:1-58-55 of the
Administrative Code, as appropriate, and to persons who hold an equivalent
license issued by the United States nuclear regulatory commission or an
agreement state;and

(4) The source or device has been registered in the sealed
source and device registry.

(1) In the event the applicant desires that
the source or device be required to be tested for leakage of radioactive
material at intervals longer than six months, he/she shall include in his/her
application sufficient information to demonstrate that such longer interval is
justified by performance characteristics of the source or device or similar
sources or devices and by design features that have a significant bearing on
the probability or consequences of leakage of radioactive material from the
source.

(2) In determining the
acceptable interval for test of leakage of radioactive material, the director
will consider information that includes, but is not limited to: